"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"

Обзор

This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.

Подробное описание

Patients diagnosed with cirrhosis and any degree of ascites that led to previous or recent hospital admission and met the inclusion criteria will be randomized into two patient groups. The first patients' group, Group A, will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics \[combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)\] and LVP as needed. The second patients' group, group B, will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day. Patients will be counseled to stay adequately hydrated and avoid alcohol intake at baseline and at every follow-up visit. Adherence, body weight, symptoms of urinary tract infection, and Sodium level will be measured after 1 and 2 weeks from the start of the therapy then at the end of the follow-up period. At the start of participation and at the end of follow up period, a quality of life will be assessed using quality of life questionnaire for chronic liver disease patients. The patient will be interviewed by the principal investigator to fill the questionnaire to ensure understanding of each question.

Вмешательства

• Препарат Dapagliflozin
  Dapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease.

Первичные конечные точки

• Number of times patient need Paracentesis to control Ascites [Срок оценки: 3 months]

Вторичные конечные точки (1)

• incidence of Cirrhosis sequelae [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.

Критерии исключения

• Child Pugh score ≥ 12 or MELD score > 25.
• Previous history of hypoglycemia or has a previous history of DKA.
• Blood pressure less than 90/60 or need dose of midodrine >15 mg/day.
• Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection.
• Pregnant or lactating female patients.
• Hypersensitivity to dapagliflozin.
• eGFR < 30 ml/min/1.73 m2
• Had hepatocellular carcinoma or any malignancy.
• Serum sodium level < 125 mg/dl.
• Portal vein thrombosis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Haram Hospital — Giza

Идентификаторы

NCT: NCT07684326 · F PH-BSU-HREC-0001625

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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